HOUSTON
Volume 14 | Issue 6
Inside This Issue
Memorial Hermann and Houston Community College Make It Easier for Employees to Attend Nursing School See pg. 8
INDEX Oncology Research......... pg.3 Mental Health...................... pg.5 Healthy Heart....................... pg.6 The Framework.................... pg.7 Financial Forecast............ pg.12
Houston Methodist Clear Lake Hospital Celebrates 10-Year Anniversary See pg. 9
June Edition 2024
FDA Finalizes Rule Regulating Laboratory Developed Tests
By Suzanne Bassett, J.D. Michael Gaba, J.D. Polsinelli, PC
T
he FDA recently issued a Final Rule to phase out its general enforcement discretion for most Laboratory Developed Tests (LDTs). The Final Rule amends FDA regulations to explicitly classify LDTs as in vitro diagnostic products (IVDs) that are regulated as devices under the Federal Food, Drug, and Cosmetic Act. It implements a four-year phaseout policy, divided into five stages, that will require all IVD manufacturers to meet the same device requirements unless the test meets a specific enforcement discretion policy. The Rule is set to significantly reshape the regulatory landscape for LDTs, with far-reaching implications for manufacturers, patients, and healthcare providers. Hospital systems that have integrated laboratories performing specialized LDTs will need to review the Rule to understand how these tests may be subject to additional regulatory requirements. We expect stakeholders to challenge the Final Rule in court, arguing that it exceeds FDA’s statutory authority. This legal battle could shape the future of LDT regulation or prevent the Final Rule from being fully implemented. Additionally, Congress may renew its efforts to establish a legislative framework for LDTs. With the Final Rule, FDA is hitting the reset button on IVD regulation to regulate all IVDs, including LDTs, similarly. For example,
the Final Rule applies to all “IVDs offered as LDTs” regardless of whether the test meets the traditional definition of an LDT, e.g., an IVD that is designed, manufactured, and used within a single laboratory. In broadening the scope, FDA is suggesting that not all laboratories have understood the limited nature of FDA’s enforcement discretion and that FDA perhaps has not been strictly enforcing its policies regarding LDTs. FDA Enforcement Discretion FDA intends to continue to exercise enforcement discretion for all or some applicable device requirements consistent with FDA’s general priorities. • Exempt From all Applicable Requirements: FDA intends to apply its enforcement discretion to all regulatory requirements such as registration and listing, premarket review, and quality system (QS) regulations for the following tests: − “1976 Type” LDTs with certain characteristics, e.g., use of manual techniques using components legally marketed for clinical use − Human Leukocyte Antigen Tests − Tests for Forensic Law Enforcement Purposes
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− LDTs manufactured within the Department of Defense or Veterans Health Administration Exempt from Premarket Review Requirements: LDTs approved by the New York State Clinical Laboratory Evaluation Program are exempt from premarket review requirements. Exempt from Premarket and Quality System Regulations (Except for Part 820, subpart M (Records)): Other regulatory requirements, such as registration and listing, MDR requirements, and corrections and removals, must be followed in accordance with the phaseout timeline: − LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system. FDA considers an unmet need to be one where there is no available FDA-authorized IVD that meets the patient’s needs. FDA is instituting this policy because the Agency recognizes that the cost of compliance with these see Rules ...page 14
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